Zinc and Biobehavioral Development in Early Childhood

Child Development Clinical Trial

Official title:

Zinc and Biobehavioral Development in Early Childhood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00589264
• Other study ID #: 5 RO1 HD045430
• Secondary ID: 5 RO1 HD045430
• Status: Completed
• Phase: N/A
• First received: December 24, 2007
• Last updated: September 8, 2014
• Start date: July 2004
• Est. completion date: June 2009

Study information

• Verified date: September 2014
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Zinc is necessary for growth and development, including the central nervous system, and zinc deficiency which is common in resource-poor settings, may adversely affect social, behavorial, cognitive and sensorimotor development. The project, located in Lima Peru, utilizes an experimental model in which children receive 10 mg supplemental zinc (or not) daily along with 10 mg iron and 1/2 mg copper from 6 months of age to 18 months of age. Beginning at 6 months of age, and at 9, 12, and 18 months, children are evaluated in multiples aspects of development. Children are also followed for their diet, growth, and health status. We hypothesize that children in this setting in which the diet is low in zinc who receive supplemental zinc will have better information processing skills, sensorimotor and behavioral development than their counterparts who do not receive supplemental zinc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: June 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 18 Months

Eligibility

Inclusion Criteria:

• Born at term of non-low birth weight

• Free of major malformations, genetic abnormalities or health problems associated with developmental delays

• Planning to remain in study area for one year

• In good general health

Exclusion Criteria:

• Low birth weight

• Non-term delivery

• Vision or hearing problems

• Anemia

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Development

Intervention

Dietary Supplement:
• zinc
10 mg elemental zinc + 10 mg elemental iron + 0.5 mg copper syrup taken daily for 1 year, from 6 to 18 months of age
• iron + copper
10 mg elemental iron + 0.5 mg copper in syrup given daily for one year from 6 months to 18 months of age

Locations

Country	Name	City	State
Peru	Instituto de Investigacion Nutricional	Lima

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Instituto de Investigacion Nutricional, Peru, University of Chicago, University of Kansas Medical Center

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive development(visual attention, executive processing, vigilance)		6, 9, 12, and 18 months	No